Clinical effect of topical treatment with clindamycin-benzoyl peroxide gel compared with clindamycin lotion in mild to moderate Hidradenitis Suppurativa

Phase 1

• Conditions: Hidradenitis Suppurativa; MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-004338-13-NL
• Lead Sponsor: Department of Dermatology, Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Age =18 years.
2. Mild to moderate HS defined as a HS-PGA of 2 or 3 with at least 2 lesions in each eligible anatomical area.
3. A diagnosis of HS for more than six months prior to baseline.
4. Able and willing to give written informed consent and to comply with the study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Contraindication for treatment with either clindamycin lotion 1% or clindamycin 1%/benzoyl peroxide 5% gel.
2. Superinfection of HS lesions.
3. Current or recurrent clinically significant skin condition in the HS treatment area other than HS.
4. Presence of other uncontrolled clinically significant major disease.
5. Pregnant and lactating women.
6. The use of systemic antibiotics 14 days prior to inclusion.
7. The use of topical antibiotics or Resorcinol cream in the eligible areas 14 days prior to inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified